Label: SUPER BLUE STUFF PAIN RELIEF CREAM- menthol cream

  • NDC Code(s): 14448-314-03, 14448-314-04, 14448-314-12, 14448-314-17
  • Packager: BLUE SPRING WELLNESS, L.L.C.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Active Ingredient:

    Menthol, USP (1.4%)

    Purpose:

    Topical Analgesic

  • Uses:

    Temporary relief of minor aches and pains associated with arthritis, simple backache, sprains, strains and bruises.

  • Warnings:

    For external use only.

    Do not use

    on wounded, damaged or irritated skin.

    When using this product

    avoid contact with eyes or mucous membranes, do not bandage tightly.

    Stop use and ask a doctor if

    you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 days or clears up and occurs again within a few days.

    If Pregnant or Breast-Feeding 

    ask a health professional before use.

    Consult a doctor

    before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Apply to affected area not more than 3 or 4 time a day.

  • Other Information:

    Store at room temperature.

  • Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf(Aloe Vera Gel)Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Sali Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden)Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Extract, FD&C Blue #1

  • Questions or Comments?

    1-800-452-3700 or www.bluespringwellness.com

  • Package Labeling:85ml

    Bottle

  • Package Labeling:118ml

    Bottle2

  • Package Labeling:355ml

    Bottle3

  • Package Labeling: 5ml

    Pack

  • INGREDIENTS AND APPEARANCE
    SUPER BLUE STUFF PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14448-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    EMU OIL (UNII: 344821WD61)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TILIA CORDATA WHOLE (UNII: W5E5UB44GD)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14448-314-0385 mL in 1 CYLINDER; Type 0: Not a Combination Product11/22/2020
    2NDC:14448-314-04118 mL in 1 JAR; Type 0: Not a Combination Product11/22/2020
    3NDC:14448-314-12355 mL in 1 CYLINDER; Type 0: Not a Combination Product11/22/2020
    4NDC:14448-314-175 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/22/2020
    Labeler - BLUE SPRING WELLNESS, L.L.C. (182950118)
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